UBND TiNl-l l)\O CAlsa Y Tit

'S6: gS3/SYT- NVD

CONG HOA XA HOI CHU NGHiA VI~T NAlVIHQC I~p - Tt,l' do - H~nh plll'tc

Lao CCIi, ngayo/1 thang 8 nam 20 J7V/y cung cap thong tin lien quan

d6n tinh an roan cua thuoc

Kinh gt.'ri:- Van phong I-IDND& UBND cac huyen Bao Th~ng, Sa Pa, Bat Xar,Simacai;- Phong Y t~: Tp. Lao Cai, 8<:10Yen, Van Ban, B~c Ha, Muong Khuong;- Ban bao v~ cham s6c sire khoe can bQ tinh;- Cac doanh nghiep kinh doanh thuoc tren dia ban tinh;- Cac dan vi true thuoc,

Thuc hien van ban s6 12312/QLD- TT ngay 15/8/2017 cua Cue Quan ly DUQ'c

viec v~ viec cung dp thong tin lien quan d~n tinh an toan ella thuoc can quang c6 chuagadolinium; thuoc chua codein, trarnadol: thuoc chua hyoscine butylbromid dang tiem;thuoc chua risperidone; thuoc sat trung chira ehlorhexidine gluconate (co ban photovan ban s6 123 J 2IQLD- TT gui kern thea). f)~ dam bao sCI'dung thuoc hop ly, an toanva hieu qua, So' Y t~ tinh Lao Cai yeu cau:

1. Van phong HBND&UBND cac huyen: Bao Thimg, Sa Pa, Bat Xar, Simacai:Phong Y t~: Tp, LelO Cai, Bao Yen, Van Ban, B~c Ha, Muo-ng KhLrang thong bao ehoeac co' So' hanh ngh~ kh<:1111b~nh, ehu'n b~nh tu' nhan, nha thu6c tLr !lhan tren din ban:Cae b~nh vi~n, Trung tam y t~ cae huy~n, thanh ph6 thong bao cho cac khoa phong,phong kham da khon khu vvc, tr~m y t~ xa, phuo-ng, thi tr§n va co' sO' btm Ie thu6cthuQc ph9-111vi ctO'nvi quan Iy; Cae doanh nghi~p kinh doanh thu6c thong bao eho eacnha thu6c, qUdy thu6c eua doanh nghi~p cac thong tin lien quan o~n tinh an toan, hi~u

\qua elia cae thu6e neu tren.

2, Cac cO' sO' y t~ tang cuo-ng thea doi tae dvng khong mong lllu6n cCLathu6etrong qua trinh sCI'd~lI1g va luu hanh, phat hi~n va xu tri cae truo'ng .hQ'p xay ra phiinCrngc6 lwi eua cae thu6e neu tren (rdu co), glri bao eao phan Crnge6 h9-i eClathu6e (i1.iuco) v~ SO'y t~ va Trung tam Qu6e gin v~ thong tin thu6e VEl thea doi phan Crngc6 h9-ieua thu6e (J3-J 5 Le Thanh Tong, Qu¢in 110an Kiim, Hit N9i).

SO' Y t~ thong belo d~ cac 00'11 vi bi~t va tlwe hi~n.l. tLNo'i nh(in:- N 1m tren;- Giam c16c sO';- Trana T1'01' Ser Y tS''" . ,- Phong NVY;- LLru: VT, NVD.ft)

Trfln Th! lVlinh

e()NG HO~'Y0-nOI CHUNGH~ '?tT NAM~BQcl~R'~Tl;l~o"H~nhphuc

BOYTE ,cue QU,:ANL¥ DUQ~

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Hq N9i, ngdy .Ar. ~h{mg..g ... nam 2'017

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PIflj I.il)cfE~pn~~ttho\tgtin lj~n quan.:!ae'n4inhan :toan eua illUDe

(Dinht,kem the()j;~ng 'van$~:>~t6!~?1'~n;f).;'P'Ftlgay;ly;thang g f -nam201:'7)1. Thuoe ean~quang,'C6ch:ua¥gadc.jliftium: '1.1.Ng~y 07/41'2017 .'; ·!eni.~k~t,danh gia, Uy ball£>anh"?la nguy ct'1Clmh

giac dircc (PR:AC) cua Co ,.' lY>\Ol1qcChau Au (EMA:)i:~a,~uy~n can tamdmg liru c6 chua gaQoliniqll1id~ng;tien:lJililim~ch, 'gadopentetic va gad;over;sel~4e.

.ban [)~ giapb\lc'vevi~c

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nguy CCI cua mol benh nhan tnroo khi sa .dung lieu l~p lai. Benh nhan va ngirci L

s6e benh nhan nen trao dOi v¢:L~aq si;di~U:.tri cua ho neu hQ co-thac mac v~ viecdung cac thuoc can.quang chua. gadolinium dt! chup cong hirong ttr.

2. Thufic chua hoat cbal~q9d,f!il)\(1~19i~u.tr]-ho Va, gi,am .<1aU,tthuoc giam dauchua hoat ch,at trapl;tdol:. c~,'jt:y~< .

2.1. N;gay20/4/2017. C~.q~:<#tQ\l~01y' Duqc va Thl1e,(~.~~m¥oa ~¥1'1(.'thong baogi6i han sa dung codellj'ya t:~[l'lado10 tre em. ate ~hU0en~y.eo nht ..•'..•.".co nghiem trong, bao g6m~hb: qh~ h0~e ~6 tho va tit vong, nhUn~;nguy CCIn . ay.ra n~hi~m ~9~~ h~ b f:r' ,~eR~£:l:f2:,:~; . ~~~n .Y~ti,p~p thl,1(1q ch~fl1'?Cllltha~ ph~~eodem V~':;~!i'fa,cap tbp_:.. !~,;tta;PJatl;,=: ,>,.qe:.~~Arl!h~q\!~:~tc~·S,)1,.PW}g:g~p dOltu<;ma_nguO'l)gn.~A cU,n ":!, (\!1~~U~~l}}~~,OJ~l~J~qslI',d~ng:~p4~~B:'y~q~ama,dolSpophV nu eha con bu ao kha nfillg 'g{\;y;'h~;~en.tre nho dang b~~., DOng:tPO'l, FDA cungdna ra nhfrng khuy~n d.o eno c~J;~:"yt~, cb6my va ngum c~ifu S6Cli~;'atghim thi~unguy CCI e6 th€ xciyra. 1f.~J~~ ';, .

'. "I '\'.f '2.2.l?P~ da~~ y~u 9~U'l~11{l:~:~6,llh~p thu6c. eua t~L~~.~~q ~ii7?'rPPI{Il1 tiju6e k~

·~~ ..c6 ehuaeactharib ph~:mn~J.l;tf;~h,eg th~iFDA y~u c~u b6;su;p~nbyc;sau:- Codein kh6ng sir d6'i(H~utri.c)giam dau va ho,. Tramadol1 1hllOng,duQ'esa

d\lng d~ dieu tn dau .- Qh~ng ciU" ....,";n" '~1

thu~t ottt·aintlJ~n"vaf:M.€Jlac:el1ldinhi' '. .. . .

'.. . . - C~\~ao *ong 19lH.¥~W~k~S&ta!J~geodein va tFarrta~£l di~Utanh::ilii~~ttlentu 12 den 18';tu6i qeo phl'n:o~e'C<5'eactlli~ tr~ng Qenlt. ribv Bg~g,.,thqkhlng{ldotttenghen ho~c b~nh ph6i nghiem t~9ng, da.y l~ nhfrng yeu,t6 Hllll"tangnguy co eua nhqng~~M ~~ .

- Ciinh bao ba, .tramadol -,"''''''"'',",,JNhiingnghiem

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!Ju6i beo phi::ho@,cco cac tlnh tra.ng benh nhu ngung tho khi ngu do t~c nghen hoacr benh phdi nghiern trong, day la nhtmg yeu t6 lam tang nguy co cua nhtrng vm· d~ h~

ha:pnghiem !f;Q'ngCcachi d!w.~ilw ~au yadi~u ttl ho).Cue Q,;.an ly iJ)uqc 7i:J3~"'iI0+e¥se';GR/;r'0I,1gvan. glfLcac'dan vida.p.g lcy,slu!xua:t

thu6c yeu ,etta va hl:t&ngd,~~ '. ;~P.Pb~~!bO sung. cac tl'lopg ..tin clmh .bao n~y vaonhan va t(1~ltit~g,d® sa ,d~~. ~c..lh~1.~~['p6,;li~nquail!

3.Thu6c chlia ho~t.~h ::hyo,schteE,{jutylbromi(le d,~ngtiemeTrong m ph;m Dru9 •..Safety U~dat~ fa thang 2 nam 2017, ga guan Q4,an ly

Diroc phfim '\facad :sao P~,~'! te;;''Arlh,t$R~)c6 cilnh bab vl'ngzJ.y crt gijp phdinhiing tac df!,ng bat lai ng~iern~~t~~ngtghi'lSUdung cac thuoe hyospine butylbromidedgng {iem - g Q,~nhnh6tl}qiJhfnh tim ..'ijleo d6, thOng,til)~e<:lcm;f"(la cac thu6c nayse~uqcq~ tph~. . . tac d\lIlg.b~tl~'ngbi~xp. tfQng,q.nhungb~P!bnh~' :'~i~b~nhtim. D6,qg . dUa fa khuy~n~cao;Cllo.cace~ll;b~Yt¢'~~: . . "

"HYq'~~meb? th~ gAyfa MUng tac a\lng'bat'l<;tinglii~mtnmg, baQ'g:Sitl: nhfp tim va phao ung phan ;v~. i,,'

- Ctlngiam ch~t .cling nhu nh~ Ivc cap cUt!,khl,q~t)::thi~t.

_HYQscine butylbforWd.{P;~ilgtr~fuvan tiep t~c ch6rrgdli dpm cho b~nhnhfulbi nhip tim nha.nh.·· , "

4. 'FllY;9~chua bo~~·,t1b3;t;:vi~peni.d:"!>-.~:4.1.. . h<;>cY t~i~'lI),g~l~QrefIllB~n

, ",'!i!Io..-

su dung cho cac typ khac cua sa sut trf tue nita (sa sut tri tue th~ hem hQ'P1sa sut trl'; 't" .'. do-rnach.mau]. '

4.2. Quy€t dinh tucmgCtv';chrl~*daduqc dira ra bCri.CCIquan Quartly Y t~Canada(Health Canada) va Co quantQ~~n;'lfd.~;S~phftm di~utri Uc(TG1~·ilE~~~ih~them then giansir dvngrisperld'()1j::d!''di~utrij'ngtmh~ncac:hanp viga:r,'~~}~~~di~nb benh nhan sa sut tri tue do'Ale1ei1ner muC d¢ trung bmh d~h n~ng kl1O'rig·(lap;'Url~ivoi d.~bien pl\3.J?kh6'!_g<lllJ\gi~~ v~,M nguy co gay hai cho blin:tl1an hO~¢\pg~khac la khO:ng..qua 6tuful. ....•..•.....•......... > .r : ..•.

5. 'Ehlldc.sattrbng n.gIQAli(JJ.lk(ftlqJl;··n(~~tchatchlorhexldine glpconate:Co QllaJ}'!QJ4aJ;):ny . Ky·(E;[)r\) d~ caM/bae>:,_ cac";i5.~lw;mig'di l(hotKhe'hay kb6 the,

simg m~tt.. .' .y va c6 . ... . uQ.:nshon nhtr« . ..nghiem . .. baa cao ii~11-' slurpham~ahrUtl Oa'dtic}csu . chua chlorhexidineglucon.ate;7'> .

_Mi hit' a ' CaO,cCll.a.cacp'Han Un..·.,"g·;.,;di.····uugngh.i 'em.. . ,m g.P . ' ' 't#Qnglienquan d~n1CaC t\le tangtrong!c~dna:Il).liK~j:day.

.l'IJ,;;.1!X3;.. oii san ,(Cu~t c~p nh~t t~eir thu6c chua" ..h,,,,,."" . da, sue nli~ngi l~t'(mong

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